NCT07322094

CATALINA-4: A Study to Investigate the Safety and Efficacy of TORL-1-23 With Chemotherapy Given Before Initial Surgery in Women With Advanced Stage Ovarian Cancer

CATALINA-4: Phase 1B/2 Study of TORL-1-23 With Neoadjuvant Chemotherapy and Interval Cytoreductive Surgery in Newly Diagnosed Patients With Advanced Stage Ovarian Cancer

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: TORL Biotherapeutics, LLC · Industry
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A Phase 1B/2 Study to Investigate the Safety and Efficacy of TORL-1-23 with Chemotherapy Given Before Initial Surgery in Women with Advanced Stage Ovarian Cancer

Conditions

• FIGO Stage III and IV Ovarian Cancer
• Fallopian Tube Cancers
• Primary Peritoneal Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	TORL-1-23 and paclitaxel	TORL-1-23 and paclitaxel
COMBINATION_PRODUCT	TORL-1-23 and carboplatin	TORL-1-23 and carboplatin
COMBINATION_PRODUCT	TORL-1-23, paclitaxel, and carboplatin	TORL-1-23, paclitaxel, and carboplatin

Timeline

• Start date: 2025-12-10
• Primary completion: 2027-12-01
• Completion: 2028-01-01
• First posted: 2026-01-07
• Last updated: 2026-01-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study